RecruitingPhase 1

A Study of LY3971297 in Participants With Heart Failure

A Phase 1, Single-Blinded, Single-Ascending Dose Study to Evaluate the Safety and Tolerability of a Single Dose of LY3971297 in Participants With HFpEF and Participants With HFrEF

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit, 5 visits
  • Time periods mentioned: 4 days
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body."
  • "For each participant, the study will last about 2 months and will include 1 inpatient visit lasting approximately 4 days and 5 outpatient visits."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and side effects of LY3971297 in people with heart failure whose hearts pump with preserved or reduced strength. Blood tests will show how the body handles the drug and how the drug affects the body. The study lasts about 2 months, with one hospital stay of about 4 days and 5 clinic visits.

The main purpose of this study is to assess how well LY3971297 is tolerated and what side effects may occur in participants with heart failure with preserved ejection fraction (HFpEF) and participants with heart failure with reduced ejection fraction (HFrEF). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 2 months and will include 1 inpatient visit lasting approximately 4 days and 5 outpatient visits.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have long-term heart failure with symptoms that limit physical activity (NYHA Class II–III), and have received recommended treatment for at least 6 months.
  • Have no changes to heart failure medicines or doses for at least 4 weeks before screening or during screening, and none planned for the next 90 days. Take a stable dose of a vasodilator, a medicine that widens blood vessels, for at least 4 weeks, with no changes planned during the study.
  • Have a kidney filtering test result (eGFR) of at least 30 and a top blood pressure number above 110 at screening and enrollment.
  • Have a body mass index (BMI), a measure of weight compared with height, from 18.5 to 40.
  • Be unable to become pregnant and have veins that allow blood draws.
  • For preserved-strength heart failure: have a record of signs or symptoms of this condition and a heart pumping measure (LVEF) above 45%.
  • For preserved-strength heart failure: meet heart chamber size and blood test limits. The left upper heart chamber size index must be above 34 with a normal rhythm or above 40 with atrial fibrillation (AF), an irregular rhythm. The NT-proBNP heart strain blood test must be above 300 without AF or above 850 with AF.
  • For reduced-strength heart failure: have a record of signs or symptoms of this condition, a heart pumping measure below 40%, and an NT-proBNP heart strain blood test above 600 without AF or above 900 with AF.

Who can't join

  • Have allergies to related drugs or study drug ingredients, a significant history of allergic conditions, or past trouble tolerating medicines that widen blood vessels.
  • Had a heart attack, unstable chest pain, major heart or blood vessel surgery, stroke, or mini-stroke within 90 days. Had a hospital stay for heart failure within 30 days, or recent severe worsening of heart failure needing medicines through a vein.
  • Have a top blood pressure number of 180 or more, low blood pressure with symptoms, blood pressure that drops when standing, a resting pulse above 90, or blood pressure or pulse that makes the drug unsafe.
  • Have certain heart muscle or birth-related heart diseases, serious heart valve narrowing or leaking, unsafe fainting spells, more than moderate high blood pressure in the lungs, or a serious or uncontrolled irregular heartbeat.
  • Have a mechanical heart valve, a tissue valve placed within 12 months, planned valve surgery, or a pacemaker or implanted heart shock device placed within 90 days. For reduced-strength heart failure, also excluded are people listed for a heart transplant, with a heart pump device placed or expected, or with heart rhythm coordination treatment started less than 6 months ago.
  • Have severe chronic obstructive pulmonary disease (COPD), a long-term lung disease; significant liver disease or abnormal liver tests; an active infection; or certain cancer histories within 3 years. Basal and squamous cell skin cancers are exceptions.
  • Have medicine doses that have not been stable for 4 weeks or planned dose changes during the study. Cannot avoid new prescription or over-the-counter medicines, or use or plan to use drugs called PDE5 inhibitors or soluble guanylyl cyclase activators.
  • Have recent blood or blood component donations that exceed the study's limits, which differ by country, or plan to donate during the study where prohibited.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Are diagnosed with chronic heart failure with New York Heart Association Class II-III (Heart Failure) HF symptomatology at screening and on guideline-directed HF therapy for at least 6 months prior to screening. * Have not changed optimal guideline-directed HF therapy, either medication or medication dose, in the last 4 weeks prior to screening and during screening period, and do not plan to change HF therapy for the next 90 days. * Must be on a stable dose of vasodilator therapy for at least 4 weeks prior to screening, with no dose adjustments planned during the study. * Have an estimated glomerular filtration rate of greater than or equal to (≥) 30 milliliter per minute per 1.73 square meters (mL/Minute/1.73m²) at screening. * Have systolic blood pressure (SBP) greater than (\>) 110 millimeters of mercury (mmHg) at screening and at enrollment. * Have a body mass index within the range of 18.5 to 40 kilograms per square meter (kg/m²) (inclusive). * Are individuals assigned male or female at birth, who are not of childbearing potential. * Have venous access sufficient to allow blood sampling. * Applicable to heart failure with preserved ejection fraction (HFpEF) participants only * Have left ventricular ejection fraction (LVEF) \>45 percent (%). * Left atrial volume index \>34 milliliters per square meter (mL/m²) in participants in sinus rhythm, or \>40 mL/m² in participants with atrial fibrillation (AF). * N-terminal pro-B-type natriuretic peptide (NT-proBNP) \>300 picograms per milliliter (pg/mL) for participants without AF or \>850 pg/mL for participants with AF. * Have a documented history of signs, symptoms, or both, consistent with HFpEF. * Applicable to heart failure with reduced ejection fraction (HFrEF) participants only: * Have LVEF \<40% . * NT-proBNP \>600 pg/mL for participants without AF or \>900 pg/mL for participants with AF. * Have a documented history of signs, symptoms, or both, consistent with HFrEF. Exclusion Criteria: * Have known allergies to related compounds of LY3971297 or any components of the formulation, or a history of significant atopy. * Had a myocardial infarction, unstable angina pectoris, coronary artery bypass graft surgery, revascularization or other major cardiovascular surgery, stroke, or transient ischemic attack in the last 90 days prior to screening. * Have New York Heart Association (NYHA) Class 4, acute decompensated HF (exacerbation of HF) requiring IV diuretics, IV inotropes, or IV vasodilators, within 30 days prior to screening, and/or during screening period until randomization. * Have SBP ≥180 mmHg at screening. * Have symptomatic hypotension. * Have resting heart rate \>90 beats per minute (bpm) at screening. * Have known cardiac amyloidosis, infiltrative myocardial diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic cardiomyopathy, pericardial constriction, or complex congenital heart disease. * Have any history of moderate-to-severe stenosis of the mitral and/or aortic valve or severe mitral and/or aortic regurgitation. * Have any history of moderate-to-severe tricuspid or pulmonic valve stenosis or severe tricuspid or pulmonic regurgitation. * Have a history of syncope that, in the opinion of the investigator, may affect the participant's safety. * Bioprosthetic valve replacement within 12 months prior to screening or any history of mechanical valve replacement, or planned valve replacement or repair during the study period. * Have any history of greater than moderate pulmonary hypertension. * Have a pacemaker or implantable cardioverter-defibrillator placement within 90 days prior to screening. * Have severe chronic obstructive pulmonary disease (COPD). * Have clinically significant or uncontrolled cardiac arrhythmia. * Have a significant history of, or presence of, hepatic disease, including any abnormal liver function tests. * Have, within 3 years prior to screening, a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (Exceptions: basal or squamous cell skin cancer). * For US sites: have donated blood of more than 500 mL within the previous 90 days of screening or intend to donate blood during the course of the study. * For Japan sites: have donated any blood within the last 4 weeks, any apheresis (blood components) within the last 2 weeks, at least 400 mL of blood within the last 16 weeks for female participants or 12 weeks for male participants, or at least 800 mL of blood for female participants or 1200 mL of blood for male participants within 12 months. * Other sites: Participants who have recently donated blood or blood components, or who intend to donate during the course of the study. * Have not been on a stable dose of medications for at least 4 weeks prior to screening, or have planned dose adjustments during the study. * Participants must abstain from taking new prescription or nonprescription drugs. * Have concurrent use or intend to use phosphodiesterase 5 inhibitor or soluble guanylyl cyclase activators. * Have any history of intolerance to vasodilator medications that, in the opinion of the investigator, would put them at risk of not tolerating study drug. * Have BP and/or pulse rate constituting a risk when taking the Investigational Medicinal Product (IMP). * Are diagnosed with orthostatic hypotension. * Show evidence of an acute infection with fever or infectious disease at screening. * Applicable to HFrEF participants only * Have been listed for cardiac transplantation and/or anticipated or implanted ventricular assist device. * Have received cardiac resynchronization therapy for less than 6 months. * Hospitalization for heart failure within 30 days of screening.

Study sites (4)

MI

MO

NC

TX